Tag Archives: Pharmaceutical Manufacturer

New VA Policy to Have Immediate Impact on Many Pharmaceutical Manufacturers, Suppliers

In a significant policy reversal that will affect many pharmaceutical manufacturers and suppliers – and that will require immediate action by many pharmaceutical manufacturers – the Department of Veterans Affairs is now requiring that all covered drugs under the Veterans Health Care Act be offered on Federal Supply Schedule (FSS) contracts, regardless of whether they … Continue Reading

California AG’s Guidance on California Online Privacy Protection Act

The California Attorney General, Kamala D. Harris, has issued a long-awaited guide on how companies can comply with the California Online Privacy Protection Act (CalOPPA). CalOPPA applies to all companies which collect personally identifiable information from California residents online, regardless of whether that information is collected via a commercial website or a mobile application. This … Continue Reading

Manufacturer, Group Payment Organization, and Physician Financial Information Slated For Disclosure, May Spur False Claims Act Activity

As mentioned on our Health Industry Washington Watch blog, pharmaceutical and medical device manufacturers and group purchasing organizations (GPO) are currently in the process of submitting detailed 2013 payment and investment interest data to the Centers for Medicare & Medicaid Services. The submission of this data, as dictated by the Physician Payment Sunshine Act, is intended to highlight certain financial relationships between the manufacturers and GPOs and physicians. With some exceptions, this data will become public by September 1, 2014, at which time the Department of Health and Human Services' Office of the Inspector General, Department of Justice, and relators' attorneys will likely analyze the data to initiate investigations and support complaints under the federal False Claims Act.… Continue Reading

FDA Draft Guidance Encourages Companies to Study Drugs for Treatment of CFS and ME and Provides Roadmap to Approval for this Indication

The FDA recently released draft guidance designed to accelerate the development and review process for drugs intended to treat Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME), a condition for which there is currently no FDA-approved treatment. Though non-binding, the guidance should help drug manufacturers design and execute studies that are more likely to succeed in satisfying the FDA clearance requirements that there be "substantial evidence" of the efficacy of a product and an acceptable risk/benefit profile. The guidance will become finalized following the end of its notice/comment period on May 12, 2014.… Continue Reading

Don’t Forget: FDA Frequents Facebook

FDA's Office of Prescription Drug Promotion has warned a Swiss drug company about failing to include risk information and omitting material facts regarding its products. What makes these particular violations noteworthy is that they occurred on the company's Facebook page. FDA became aware of the company's Facebook promotion through its own monitoring and surveillance program.… Continue Reading
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